Quality Assurance Associate

Location: Sunnyvale, CA

Summary:

The Quality Assurance Associate will be an essential part of the Operations team in order to assure compliance to quality system requirements of finished product; identifying discrepancies related to traceability, rework and change order implementation, driving resolution of such discrepancies with the appropriate parties and authoring release of product to customers.

The right candidate will develop into the leader of the Product Release team, becoming an expert in thorough and accurate product history record review and the governing department as well as those of the internal customers they support.  While adhering to the procedures which govern the execution of their duties, they will continually seek out process improvement opportunities for presentation to their team and management and balance any resulting improvement projects with their standard duties such that all department goals are met on-time.

Job Description:

  • Reviews and approves device history records, ensuring compliance with device master record and other quality system requirements
  • Provides authorization to release product, including Systems, Instruments and Accessories for distribution to customers
  • Documents non-conformances in the company electronic documentation system
  • Works collaboratively with internal customers to resolve non-conformance in a timely manner
  • Reviews sterilization records generated by external vendors and approves release of sterilized product to customers
  • Generates certificates of conformance for customers in Japanese market
  • Develops and maintains reports related to areas of responsibility and reports status and metrics regularly to management
  • Performs material transactions in a timely fashion and performs regular cycle-counting activities to maintain accurate inventory
  • Participates in or leads process improvement projects as directed by management
  • Performs work according to production schedule, including working overtime as required
  • Other duties as assigned by management

Requirements:

  • 1-2 years of experience in a Product Quality environment or 2+ years in a relevant manufacturing environment
  • Independently manages areas of responsibility with minimal directions from teach leadership
  • Exceptional analytical, problem-solving and root-cause analysis skills
  • Excellent verbal and written communication skills
  • Demonstrated understanding of or aptitude to understand device and regulatory requirements
  • Demonstrated ability to be a quick learner and understand complex products and processes